The Glatiramer Acetate Injection is an AP-rated substitutable generics of Copaxone, 20 mg/ml, 40 mg/ml.
It is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Zydus’ generic Glatiramer Acetate Injection, developed in collaboration with Chemi S.p.A., will be manufactured entirely in Europe.
Glatiramer Acetate Injection had annual sales of US$ 719 million in the United States (IQVIA MAT Mar 2025).
Dr Sharvil Patel, managing director, Zydus Lifesciences, said: “Zydus, together with Chemi, is proud to receive FDA approval for a substitutable generic version for this important therapy.
This approval underscores Zydus' leadership in bringing complex, differentiated generics to market, reinforcing our commitment to providing a comprehensive range of therapeutic choices for patients.”
The Zydus Group now has 426 approvals and has so far filed 492 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The company reported a 29.62% jump in consolidated net profit of Rs 1,023.5 crore in Q3 FY25 compared with Rs 789.6 crore in Q3 FY24. Revenue from operations increased 16.96% YoY to Rs 5,269.1 crore during the quarter.
The scrip shed 0.63% to currently trade at Rs 866.35 on the BSE.